Geoff Mulvihill stories from The Center for Public Integrity2018-03-19T10:39:40-04:00https://www.publicintegrity.org/node/20195/rssOpioid makers paid millions to advocacy groups that promoted their painkillers amid addiction epidemic http://www.publicintegrity.org/node/21567A report by U.S. Sen. Claire McCaskill finds opioid drugmakers gave $10 million to advocacy groups that could help spread their message.RTT;Health;Medicine;Drug culture;Oxycodone;Morphinans;Morphine;Euphoriants;Opioid;Opioid epidemic;Fentanyl;Purdue Pharma2018-02-13T09:49:29-05:002018-02-12T19:30:00-05:00<p>Companies selling some of the most lucrative prescription painkillers funneled millions of dollars to <a href="https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis">advocacy groups that in turn promoted the medications’ use</a>, according to a report released Monday by a U.S. senator.</p>
<p>The investigation by Missouri’s Sen. Claire McCaskill sheds light on the opioid industry’s ability to shape public opinion and raises questions about its role in an overdose epidemic that has claimed hundreds of thousands of American lives. Representatives of some of the drugmakers named in the report said they did not set conditions on how the money was to be spent or force the groups to advocate for their painkillers.</p>
<p>The report from McCaskill, ranking Democrat on the Senate’s homeland security committee, examines advocacy funding by the makers of the top five opioid painkillers by worldwide sales in 2015. Financial information the companies provided to Senate staff shows they spent more than $10 million between 2012 and 2017 to support 14 advocacy groups and affiliated doctors.</p>
<p>The report did not include some of the largest and most politically active manufacturers of the drugs.</p>
<p>The findings follow a similar investigation launched in 2012 by a bipartisan pair of senators. That effort eventually was shelved and no findings were ever released.</p>
<p>While the new report provides only a snapshot of company activities, experts said it gives insight into how industry-funded groups fueled demand for drugs such as OxyContin and Vicodin, addictive medications that generated billions in sales despite research showing they are largely ineffective for chronic pain.</p>
<p>“It looks pretty damning when these groups were pushing the message about how wonderful opioids are and they were being heavily funded, in the millions of dollars, by the manufacturers of those drugs,” said Lewis Nelson, a Rutgers University doctor and opioid expert.</p>
<p>The findings could bolster hundreds of lawsuits that are aimed at holding opioid drugmakers responsible for helping fuel an epidemic blamed for the deaths of more than 340,000 Americans since 2000.</p>
<p>McCaskill’s staff <a href="https://www.publicintegrity.org/2017/03/28/20785/democratic-senator-investigates-drugmakers-role-opioid-epidemic">asked drugmakers to turn over records</a> of payments they made to groups and affiliated physicians, part of a broader investigation by the senator into the opioid crisis. The request was sent last year to five companies: Purdue Pharma; Insys Therapeutics; Janssen Pharmaceuticals, owned by Johnson &amp; Johnson; Mylan; and Depomed.</p>
<p>Fourteen nonprofit groups, mostly representing pain patients and specialists, received nearly $9 million from the drugmakers, according to investigators. Doctors affiliated with those groups received another $1.6 million.</p>
<p>Most of the groups included in the probe took industry-friendly positions. That included issuing medical guidelines promoting opioids for chronic pain, lobbying to defeat or include exceptions to state limits on opioid prescribing, and criticizing landmark prescribing guidelines from the U.S. Centers for Disease Control and Prevention.</p>
<p>“Doctors and the public have no way of knowing the true source of this information and that’s why we have to take steps to provide transparency,” said McCaskill in an interview with The Associated Press. The senator plans to introduce legislation requiring increased disclosure about the financial relationships between drugmakers and certain advocacy groups.</p>
<p>A <a href="https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis">2016 investigation by the AP and the Center for Public Integrity</a> revealed how painkiller manufacturers used hundreds of lobbyists and millions in campaign contributions to fight state and federal measures aimed at stemming the tide of prescription opioids, often enlisting help from advocacy organizations.</p>
<p>Bob Twillman, executive director of the <a href="http://www.integrativepainmanagement.org/">Academy of Integrative Pain Management</a>, said most of the $1.3 million his group received from the five companies went to a state policy advocacy operation. But Twillman said the organization has called for non-opioid pain treatments while also <a href="https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis">asking state lawmakers for exceptions to restrictions</a> on the length of opioid prescriptions for certain patients.</p>
<p>“We really don’t take direction from them about what we advocate for,” Twillman said of the industry.</p>
<p>The tactics highlighted in Monday’s report are at the heart of lawsuits filed by hundreds of state and local governments against the opioid industry.</p>
<p>The suits allege that drugmakers misled doctors and patients about the risks of opioids by enlisting “front groups” and “key opinion leaders” who oversold the drugs’ benefits and encouraged overprescribing. In the legal claims, the governments seek money and changes to how the industry operates, including an end to the use of outside groups to push their drugs.</p>
<p>U.S. deaths linked to opioids have quadrupled since 2000 to roughly 42,000 in 2016. Although initially driven by prescription drugs, most opioid deaths now involve illicit drugs, including heroin and fentanyl.</p>
<p><a href="http://www.purduepharma.com/">Purdue Pharma</a>, the maker of OxyContin, contributed the most to the groups, funneling $4.7 million to organizations and physicians from 2012 through last year.</p>
<p>In a statement, the company did not address whether it was trying to influence the positions of the groups it supported, but said it does help organizations “that are interested in helping patients receive appropriate care.” On Friday, Purdue announced it would no longer market OxyContin to doctors.</p>
<p><a href="https://www.insysrx.com/">Insys Therapeutics</a>, a company recently targeted by federal prosecutors, provided more than $3.5 million to interest groups and physicians, according to McCaskill’s report. Last year, the company’s founder was indicted for allegedly offering bribes to doctors to write prescriptions for the company’s spray-based fentanyl medication.</p>
<p>A company spokesman declined to comment.</p>
<p>Insys contributed $2.5 million last year to a <a href="https://uspainfoundation.org/">U.S. Pain Foundation</a> program to pay for pain drugs for cancer patients.</p>
<p>“The question was: Do we make these people suffer, or do we work with this company that has a terrible name?” said U.S. Pain founder Paul Gileno, explaining why his organization sought the money.</p>
<p>Depomed, Janssen and Mylan contributed $1.4 million, $650,000 and $26,000 in payments, respectively. <a href="http://www.janssen.com/">Janssen</a> and <a href="http://www.mylan.com/">Mylan</a> told the AP they acted responsibly, while calls and emails to <a href="http://www.depomed.com/">Depomed</a> were not returned.</p>
<p><em>Perrone and Mulvihill report for <a href="https://apnews.com/2d6203cfb7d34ca68f2bb579c8e80862?utm_campaign=SocialFlow&amp;utm_source=Twitter&amp;utm_medium=AP">The Associated Press</a>.</em></p>
<p><strong>READ MORE:</strong></p>
<p><strong><a href="https://www.publicintegrity.org/2016/09/18//politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis">Politics of pain: Drugmakers fought state opioid limits amid crisis</a></strong></p>
<p><strong><a href="https://www.publicintegrity.org/2016/09/19/20201/pro-painkiller-echo-chamber-shaped-policy-amid-drug-epidemic">Pro-painkiller echo chamber shaped policy amid drug epidemic</a></strong></p>
<p><strong><a href="https://www.publicintegrity.org/2016/12/15/20544/drugmakers-push-profitable-unproven-opioid-solution">Drugmakers push profitable, but unproven, opioid solution</a></strong></p>
Purdue Pharma, the maker of OxyContin pills, gave $4.7 million to advocacy groups that have promoted the medications’ use, according to a new report from U.S.&nbsp;Sen. Claire McCaskill.
Matthew Perronehttps://www.publicintegrity.org/authors/matthew-perroneGeoff Mulvihillhttps://www.publicintegrity.org/authors/geoff-mulvihillDrugmakers push profitable, but unproven, opioid solutionhttp://www.publicintegrity.org/node/20544Drugmakers push policies boosting unproven new opioid formulations as a solution to the addiction epidemic.Ethers;Morphinans;Morphine;Euphoriants;Phenols;Neurochemistry;Opioid;Neuropsychology;Nervous system2016-12-15T10:53:35-05:002016-12-15T05:00:06-05:00<p><em><strong>Editor's note:</strong>&nbsp;This is the latest installment of an ongoing&nbsp;series. The first parts&nbsp;explored&nbsp;the&nbsp;<a href="https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis">state political efforts surrounding&nbsp;opioids</a>&nbsp;and how a loose&nbsp;coalition of drugmakers and&nbsp;industry-backed nonprofits shaped the&nbsp;<a href="https://www.publicintegrity.org/2016/09/19/20201/pro-painkiller-echo-chamber-shaped-policy-amid-drug-epidemic">federal response to the opioid crisis</a>.&nbsp;</em></p>
<p>Pilloried for their role in the epidemic of prescription painkiller abuse, drugmakers are aggressively pushing their remedy to the problem: a new generation of harder-to-manipulate opioids that have racked up billions in sales, even though there’s little proof they reduce rates of overdoses or deaths.</p>
<p>More than prescriptions are at stake. Critics worry the drugmakers’ <a href="https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis">nationwide lobbying campaign</a> is distracting from more productive solutions and delaying crucial efforts to steer physicians away from prescription opioids — addictive pain medications involved in the deaths of more than 165,000 Americans since 2000.</p>
<p>“If we’ve learned one lesson from the last 20 years on opioids it’s that these products have very, very high inherent risks,” said <a href="https://www.jhsph.edu/faculty/directory/profile/2761/caleb-alexander">Dr. Caleb Alexander</a>, co-director of Johns Hopkins University’s Center for Drug Safety and Effectiveness. “My concern is that they’ll contribute to a perception that there is a safe opioid, and there’s no such thing as a fully safe opioid.”</p>
<p>The latest drugs — known as abuse-deterrent formulations, or ADFs — are generally harder to crush or dissolve, which the drugmakers tout as making them difficult to snort or inject. But they still are vulnerable to manipulation and potentially addictive when simply swallowed. National data from an industry-sponsored tracking system also show drug abusers quickly drop the reformulated drugs in favor of older painkillers or heroin.</p>
<p>In the last two years, pharmaceutical companies have made a <a href="https://www.publicintegrity.org/2016/09/19/20201/pro-painkiller-echo-chamber-shaped-policy-amid-drug-epidemic">concerted under-the-radar push</a> for bills benefiting the anti-abuse opioids in statehouses and in Congress, where proposed legislation would require the <a href="http://www.fda.gov/">Food and Drug Administration</a> to replace older opioids with the new drugs.</p>
<p>The lobbying push features industry-funded advocacy groups and physicians, along with grieving family members, who rarely disclosed the drugmakers' ties during their testimony in support of the drugs.</p>
<p>Besides the tamper-resistant pills, ADF opioids are being rolled out in other forms, including injectable drugs and pills that irritate users when they’re snorted or contain substances that counteract highs.</p>
<p>Making painkillers harder to abuse is a common-sense step. But it’s also a multibillion-dollar sales opportunity, offering drugmakers the potential to wipe out lower-cost generic competitors and lock in sales of their higher-priced versions, which cost many times more than conventional pills. The big companies hold multiple patents on the reformulated drugs, shielding them from competition for years — in some cases decades.</p>
<p>Though abuse-deterrent painkillers represented less than 5 percent of all opioids prescribed last year, they generated more than $2.4 billion in sales, or roughly a quarter of the nearly $10 billion U.S. market for the drugs, according to <a href="http://www.imshealth.com/">QuintilesIMS</a>. The field is dominated by Purdue Pharma’s OxyContin, patent-protected until 2030.</p>
<p>“We at Purdue make certain that prescribers and other stakeholders understand that opioids with abuse-deterrent properties won’t stop all prescription drug abuse, but they are an important part of the comprehensive approach needed to address this public health issue,” <a href="http://www.purduepharma.com/">Purdue</a> spokesman Robert Josephson said in a statement.</p>
<p>Like a spokeswoman for <a href="http://www.pfizer.com/">Pfizer Inc.</a>, Josephson also noted that some public health officials, including the Food and Drug Administration, have endorsed using ADFs.</p>
<p>“We need every tool that we can have in our toolbox,” said Kentucky state <a href="http://www.lrc.ky.gov/Legislator/H066.htm">Rep. Addia Wuchner</a>, a Republican who has worked on several bills to benefit reformulated opioids. “The extra steps are worth the effort in order to prevent this escalation of more addiction.”</p>
<p>The current industry campaign draws on the same 50-state strategy that painkiller manufacturers successfully deployed to help kill or weaken measures aimed at stemming the tide of prescription opioids, a playbook <a href="http://bigstory.ap.org/article/3d257452c24a410f98e8e5a4d9d448a7/pro-painkiller-echo-chamber-shaped-policy-amid-drug">The Associated Press</a> and <a href="https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis">Center for Public Integrity</a> exposed in September.</p>
<p>The reporting detailed how opioid drugmakers and the nonprofits they help fund spent more than<a href="https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis"> $880 million on lobbying and political contributions</a> at the state and federal level over the past decade, eight times what the gun lobby reported for the same period. The money represents the drugmakers’ spending on all their legislative interests, including opioids.</p>
<p>The FDA has approved a handful of the reformulated drugs but has not yet concluded that any reduce rates of addiction, abuse or death, and the evidence gap has led to diverging views among health authorities.</p>
<p>Whereas FDA regulators emphasize the potential promise of reformulated painkillers, other government officials stress that they contain the same heroin-like ingredients as traditional opioids. An estimated 78 Americans die from heroin and prescription opioid overdoses every day.</p>
<p>“‘Abuse-deterrent’ sounds to people sometimes like ‘Oh, maybe it’s not addictive.’ But it’s no less addictive,” said <a href="https://www.cdc.gov/about/cdcdirector/">Dr. Tom Frieden</a>, head of the Centers for Disease Control and Prevention.</p>
<p>Survey results <a href="http://journals.lww.com/clinicalpain/Citation/2016/04000/Primary_Care_Physicians__Knowledge_And_Attitudes.1.aspx">published</a> this year in the Clinical Journal of Pain showed nearly half of U.S. physicians incorrectly believed that reformulated opioids are less addictive than their predecessors.</p>
<p>Many experts see a key role for ADFs in reducing the number of people who first begin abusing opioids, and some say the abuse-deterrent formulations should be the default painkiller for patients with histories of drug use, anxiety or depression. But even they worry that some drugmakers are overselling the technology. They stress that separate measures are needed for the majority of opioid abusers who ingest the pills orally.</p>
<p>“The way they’re handling the ADF is that this is the answer. And it’s not the answer — it’s part of the bigger puzzle,” said <a href="http://www.psychiatry.wustl.edu/Faculty/FacultyDetails?ID=579">Theodore Cicero</a>, a psychiatry professor at Washington University in St. Louis, who has authored several studies on the drugs.</p>
<p><strong>‘You can’t put a price tag on anybody’s life’</strong></p>
<p>Two years after the overdose that killed her 21-year-old son, Terri Bartlett traveled to Illinois’ state capital to champion an unlikely cause: revamped painkillers.</p>
<p>Bartlett’s son Michael became hooked on Vicodin and later graduated to heroin. In emotional testimony last year, she urged lawmakers to support a bill that would prioritize the new harder-to-crush pills, saying she believed her son would still be alive if abuse-deterrent formulations had been on the market then.</p>
<p>“You can’t put a price tag on anybody’s life,” she said.</p>
<p>Bartlett didn’t know then that she had been recruited into a wide-ranging lobbying campaign.&nbsp;A public relations firm hired by OxyContin-maker Purdue had helped recruit her to support the bill, along with local sheriffs and fire chiefs.</p>
<p>Her words, and similar testimony from parents of drug abusers elsewhere, reflect a tactic used by the drugmakers across the country. For instance, Purdue paid nearly $95,000 for similar lobbying efforts in New York, state records show.</p>
<p>And the industry’s fingerprints are easy to spot in other areas. Of more than 100 bills dealing with the drugs introduced in 35 states in 2015 and 2016, at least 49 featured nearly identical language requiring insurers to cover abuse-deterrent drugs, according to an analysis of data from <a href="https://www.quorum.us/">Quorum</a>, a legislative tracking service. Several of the bill sponsors said they received the wording from pharmaceutical lobbyists.</p>
<p>Since 2012, at least 21 bills related to the drugs have become law, including five that require insurers to pay for the more expensive drugs in Maine, Maryland, Massachusetts, Florida and West Virginia.</p>
<p>Wins in such states will give drugmakers momentum to successfully push for copycat laws elsewhere, noted Paul Kelly, a federal lobbyist who has worked on multistate lobbying campaigns for drugstores and major retailers.</p>
<p>“It’s like a foot in the door,” he said.</p>
<p>Drugmakers have found fierce opposition to their ADF legislation from insurers and employers who would be on the hook for the far pricier opioid variations.</p>
<p>The Illinois bill — and the 48 strikingly similar measures in other states — would require insurers to cover the drugs in the same way as other opioids, which the insurance companies argue would allow drugmakers to charge whatever they want for them.</p>
<p>“That is not the best use of our medical care resources,” Vernon Rowen, vice president of state government affairs for the insurance company <a href="https://www.aetna.com/">Aetna</a>, told Illinois lawmakers after Bartlett testified. “It totally eliminates our ability to negotiate discounts with manufacturers.”</p>
<p>New York Gov. Andrew Cuomo and New Jersey Gov. Chris Christie both vetoed such insurance mandates in the past year, citing the <a href="http://www.njleg.state.nj.us/2014/Bills/A4500/4271_V1.PDF">high costs</a> and <a href="http://static.votesmart.org/static/vetotext/54938.pdf">lack of evidence</a> that the drugs help.</p>
<p>Federal health officials also have pushed back against requirements to cover the drugs, citing the “staggering” costs. For example, a 30-day supply of Pfizer’s abuse-deterrent Embeda, a combination drug containing morphine, costs $268, while a 30-day supply of a generic morphine costs roughly $38, according to data compiled by <a href="http://truvenhealth.com/">Truven Health Analytics</a>, a company that tracks drug prices set by manufacturers.</p>
<p>The <a href="https://www.va.gov/">Department of Veterans Affairs</a>’ Dr. Bernie Good estimated that converting the 8.8 million patient system exclusively to the new reformulations would increase opioid spending more than tenfold, to over $1.6 billion annually. Good, who co-directs the VA’s program for medication safety, said the vast majority of veterans are not at risk for snorting or injecting their medications.</p>
<p>“Would the excess money to pay for abuse-deterrent products — mostly to pay for it in cases where it wouldn’t be necessary — be better spent for drug treatment centers?” he asked at a recent federal meeting on the drugs.</p>
<p>Federal estimates say at least 2.2 million Americans are addicted to prescription opioids or heroin, yet only one in five actually receives treatment, according to a Surgeon General’s <a href="https://www.surgeongeneral.gov/library/2016alcoholdrugshealth/index.html">report</a> published last month. That’s despite some $35 billion already spent annually on substance abuse programs by private and public health providers.</p>
<p>State lawmakers who support the abuse-deterrent bills often defend them as an important piece of solving the opioid puzzle, preventing more costly overdoses and hospitalizations.</p>
<p>And Fred Brason, executive director of <a href="http://projectlazarus.org/">Project Lazarus</a>, a North Carolina-based group that promotes anti-addiction policies in several states, called the focus on the drugs’ cost too narrow.</p>
<p>“You’re already spending that money at the back end,” he said. “You’re spending it at the emergency department.” He also noted the costs of addiction treatment.</p>
<p>When critics raise alarms about higher costs and limited evidence, drugmakers can rely on groups they support financially to argue their side, including the National Association of Drug Diversion Investigators, the Academy of Integrative Pain Management and the Partnership for Drug-Free Kids. Representatives from those groups have testified in favor of abuse-deterrent legislation in at least seven states.</p>
<p>NADDI president <a href="http://naddi.associationdatabase.com/aws/NADDI/asset_manager/get_file/32039/cichon-bio.pdf?ver=17787">Charlie Cichon</a> acknowledged his group receives funds from several ADF-makers, but said it views the drugs as a proven part of the solution to the opioid crisis. “We’re not testifying for Purdue Pharma’s product or Endo’s product,” he said.</p>
<p>And <a href="http://www.aapainmanage.org/profile/bob-twillman/">Bob Twillman</a>, executive director of the Academy, said, “Increased use of abuse-deterrent opioids makes it more likely that those patients who need opiates to treat their pain will be able to get them.”</p>
<p>The <a href="http://www.drugfree.org/">Partnership for Drug-Free Kids</a> did not respond to multiple requests for comment.</p>
<p>Physicians with financial ties to drugmakers play similar roles. Dr. Gareth Shemesh, a pain specialist, testified in support of a Colorado bill last year brought to the sponsoring legislator by Pfizer. Shemesh had received more than $13,500 from Pfizer that year in speaking fees, travel and meals, and more than $5,000 from Purdue the year before. He did not respond to calls for comment, but Pfizer said he was not paid to testify and did not speak on behalf of any specific product.</p>
<p>Purdue and Pfizer also have ramped up contributions to the <a href="http://www.republicanags.com/">Republican</a> and <a href="http://democraticags.org/">Democratic</a> attorneys general associations, which raise unlimited funds to help elect AGs across the country. In 2015 and 2016, they gave a total of $950,000 — more than in the previous four years combined.</p>
<p>To date, 51 attorneys general from U.S. states and territories have signed at least <a href="http://www.naag.org/assets/files/pdf/signons/20130311.Final%20FDA%20Letter.pdf">one</a> of <a href="http://www.naag.org/assets/files/pdf/signons/Final%20FDA%20Abuse%20Deterrent%20Letter.pdf">two</a> National Association of Attorneys General letters to the FDA, urging the agency to favor abuse-deterrent drugs.</p>
<p>The pro-ADF playbook even includes a bit of political theater. In at least seven states, lawmakers or advocates have pounded the reformulated pills with hammers to demonstrate how difficult they are to smash.</p>
<p>In Illinois, it was Democratic <a href="http://www.housedem.state.il.us/members/feigenholtzs/">Rep. Sara Feigenholtz</a> wielding the hammer on the same committee that heard Terri Bartlett’s testimony. The main sponsor of the bill prioritizing ADFs, Feigenholtz ranked second-highest among legislative recipients of money from Pfizer since the start of 2010, according to an analysis of data from the <a href="http://followthemoney.org/">National Institute on Money in State Politics</a>. The $6,200 she received during that period was more than she had received in the 14 previous years combined. Her bill passed the committee but later stalled in the Legislature and remains pending.</p>
<p>She did not return multiple requests for comment. Pfizer said its contributions to Feigenholtz go back 20 years and it would be “inaccurate and misleading” to suggest a tie to any one piece of legislation.</p>
<p>Bartlett said she doesn’t mind that Purdue was ultimately responsible for her invitation to testify, even though she didn’t know that at the time. She still supports the bill.</p>
<p>“I want to believe that in every pharmaceutical company there still remains some sort of humanity,” she said. “Saving life is expensive.”</p>
<p><strong>‘An addict can find a way’&nbsp;&nbsp;&nbsp;&nbsp;</strong></p>
<p>The FDA has walked a careful line on the new drugs, promoting them as a promising approach to discouraging abuse while acknowledging their real-world benefits remain largely theoretical.</p>
<p>Earlier this year, the agency highlighted the drugs in its “<a href="http://www.fda.gov/NewsEvents/Newsroom/FactSheets/ucm484714.htm">opioids action plan</a>,” issued after scathing criticism from some members of Congress that the FDA wasn’t doing enough to combat the epidemic.</p>
<p>Thus far, the agency has approved seven drugs with labeling suggesting they are “expected to” discourage abuse, based on studies conducted by pharmaceutical companies.</p>
<p>But the FDA has not yet concluded that any of the products have a “real-world impact” on measures like overdose or death, according to <a href="http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm374561.htm">Dr. Douglas Throckmorton</a>, an agency deputy director. He and other regulators predict, however, that the reformulations will eventually translate into public health results.</p>
<p>“We stand by those predictions,” Throckmorton said at a recent public meeting on the drugs. “We’re confident in the science, we’re confident in the assessments we conducted.”</p>
<p>Even some former FDA advisers who support expanded use of the drugs say they are only part of the solution. Dr. Lewis Nelson, who previously chaired an FDA panel on drug safety, notes that the drugs don’t deter the most common form of abuse: swallowing pills whole.</p>
<p>“Certainly, you might not eat one and get high,” he said. “You eat three and get high.”</p>
<p>At least one study found that while OxyContin’s reformulation coincided with many abusers switching to other drugs, other users still were able to defeat the pills’ technology and snort or inject the contents.</p>
<p>David Rook, a 40-year-old Henrico, Virginia, resident who now operates a recovery facility, was among them. Before entering treatment, he said, he would break down abuse-deterrent OxyContins and crush-resistant Opanas using water, lemon juice and a microwave.</p>
<p>“The truth is an addict can find a way to abuse a medication one way or the other,” he said.</p>
<p>A recent HIV outbreak in rural Indiana illustrates the sometimes unpredictable effect of ADFs on abusers’ behavior.</p>
<p>Approximately 210 people have tested positive for the virus in Scott County since 2014, a public health crisis linked to needle-sharing among abusers of Opana. <a href="http://www.endo.com/">Endo Pharmaceuticals</a> received approval for a reformulated version of the drug in 2011, making it harder to crush. As a result, many abusers switched from snorting the drug to injecting it with syringes, leading to the <a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1515195">spread of the blood-borne HIV virus</a>, according to the state health commissioner and other officials. &nbsp;&nbsp;</p>
<p>Endo spokeswoman Heather Zoumas Lubeski declined to comment on the outbreak, but issued a statement saying, “Patient safety has always been a top priority for Endo and we are committed to providing patients with approved products that are safe and effective when used as prescribed.”</p>
<p>The FDA declined to approve labeling claims for Opana’s anti-abuse features, noting that the drug still can easily be cooked and injected.</p>
<p>Pfizer, Purdue, Endo and <a href="http://www.tevapharm.com/">Teva Pharmaceuticals Industries Ltd.</a> spent more than $20 million between 2012 and 2015 on federal lobbying efforts that included support of a bill that would require the FDA to gradually replace current opioids with harder-to-abuse versions that become available. Teva declined comment.</p>
<p><a href="https://keating.house.gov/">Rep. William Keating</a>, D-Mass., first introduced the bill in 2012 and tried again in 2013 and 2015. Like his colleagues at the state level, he employed the hammer-smashing routine to illustrate the medications’ crush-resistant properties.</p>
<p>Keating said the industry played no part in spurring the bill, even though the head of a nonprofit association funded by abuse-deterrent drugmakers spoke at the press conference introducing his legislation. He also received $2,500 in political contributions from makers of reformulated opioids in 2011 and 2012, a small fraction of his overall fundraising haul.</p>
<p>“My interest in this stems from when I was a district attorney and I got to see the lives that were lost,” Keating said in an interview.</p>
<p>While Keating’s bill has not received a vote in Congress, the FDA already has begun moving in the direction suggested by companies, mapping out a process for removing older opioids from the market when newer versions are shown to be more effective at thwarting abuse.</p>
<p>“You don’t have to pass a bill, necessarily, to change policy,” said Dan Cohen of the <a href="http://abusedeterrent.org/Default.aspx">Abuse Deterrent Coalition</a>, which represents smaller abuse-deterrent manufacturers.</p>
<p>The lack of real-world data on reformulated opioids is the main reason some federal officials haven’t embraced them.</p>
<p>The CDC did not recommend ADFs in its landmark opioid guidelines this year, the first-ever federal recommendations for doctors prescribing the drugs. Why? Frieden, the agency’s director, said his staff could not find any evidence showing the updated opioids actually reduce rates of addiction, overdoses or deaths.</p>
<p><em>Center for Public Integrity data reporter Ben Wieder contributed to this article.</em></p>
<p><strong><em>This story was co-published with&nbsp;</em></strong><em><a href="http://bigstory.ap.org/article/2179dcb0023847879d291804d7c9270b/drugmakers-push-profitable-unproven-opioid-solution">The Associated Press</a></em><strong><em>.</em></strong></p>
Terri Bartlett looks at a framed pictured of her deceased son Michael hanging on a wall of her McHenry, Ill., home. Two years after the overdose that killed her 21-year-old son,&nbsp;Bartlett traveled to Illinois’ state capital to champion an unlikely cause: revamped painkillers.&nbsp; In emotional testimony last year, she urged lawmakers to support a bill that would prioritize the new harder-to-crush pills, saying she believed her son would still be alive if abuse-deterrent formulations had been on the market then.
Matthew Perronehttps://www.publicintegrity.org/authors/matthew-perroneGeoff Mulvihillhttps://www.publicintegrity.org/authors/geoff-mulvihillLiz Essley Whytehttps://www.publicintegrity.org/authors/liz-essley-whytePolitics of pain: Drugmakers fought state opioid limits amid crisishttp://www.publicintegrity.org/node/20200Makers of prescription painkillers have tried to weaken state measures aimed at stemming the opioid crisis that has killed 165,000.Morphine;Neurochemistry;Opioid;Neuropsychology;Nervous system;Drug overdose2016-12-15T09:07:28-05:002016-09-18T00:01:02-04:00<p><strong><em>Editor's note:</em></strong><em>&nbsp;This is the first installment of an ongoing&nbsp;series. The next stories&nbsp;explore&nbsp;how a loose&nbsp;coalition of drugmakers and&nbsp;industry-backed nonprofits shaped the&nbsp;<a href="https://www.publicintegrity.org/2016/09/19/20201/pro-painkiller-echo-chamber-shaped-policy-amid-drug-epidemic" target="_blank">federal response to the opioid crisis</a>&nbsp;and how drugmakers are pushing a&nbsp;<a href="https://www.publicintegrity.org/2016/12/15/20544/drugmakers-push-profitable-unproven-opioid-solution" target="_blank">profitable, yet unproven, remedy</a>.</em></p>
<p>The makers of prescription painkillers have adopted a 50-state strategy that includes hundreds of lobbyists and millions in campaign contributions to help kill or weaken measures aimed at stemming the tide of prescription opioids, the drugs at the heart of a crisis that has cost 165,000 Americans their lives and pushed countless more to crippling addiction.</p>
<p>The drugmakers vow they’re combating the addiction epidemic, but <a href="http://bigstory.ap.org/article/86e948d183d14091a80f5c3bfb429c68/drugmakers-fought-state-opioid-limits-amid-crisis">The Associated Press</a> and the <a href="http://www.publicintegrity.org">Center for Public Integrity</a> found that they often employ a statehouse playbook of delay and defend that includes funding advocacy groups that use the veneer of independence to fight limits on the drugs, such as OxyContin, Vicodin and fentanyl, the narcotic linked to Prince’s death.</p>
<p>The mother of Cameron Weiss was no match for the industry’s high-powered lobbyists when she plunged into the corridors of New Mexico’s Legislature, crusading for a measure she fervently believed would have saved her son’s life.</p>
<p>It was a heroin overdose that eventually killed Cameron, not long before he would have turned 19. But his slippery descent to death started a few years earlier, when a hospital sent him home with a bottle of Percocet after he broke his collarbone in wrestling practice.</p>
<p>Jennifer Weiss-Burke pushed for a bill limiting initial prescriptions of opioid painkillers for acute pain to seven days. The bill exempted people with chronic pain, but opponents still fought back, with lobbyists for the pharmaceutical industry quietly mobilizing in increased numbers to quash the measure.</p>
<p>They didn’t speak up in legislative hearings. “They were going individually talking to senators and representatives one-on-one,” Weiss-Burke said.</p>
<p>Unknowingly, she had taken on a political powerhouse that <a href="https://www.publicintegrity.org/2016/09/18/20203/pharma-lobbying-held-deep-influence-over-opioids-policies">spent more than $880 million nationwide</a> on lobbying and campaign contributions from 2006 through 2015 — more than 200 times what those advocating for stricter policies spent and more than eight times what the formidable gun lobby recorded for similar activities during that same period.</p>
<p>The pharmaceutical companies and allied groups have a number of legislative interests in addition to opioids that account for a portion of their political activity, but their steady presence in state capitals means they’re poised to jump in quickly on any debate that affects them.</p>
<p>Collectively, the AP and the Center for Public Integrity found, the drugmakers and allied advocacy groups employed an annual average of 1,350 lobbyists in legislative hubs from 2006 through 2015, when opioids’ addictive nature came under increasing scrutiny.</p>
<p>“The opioid lobby has been doing everything it can to preserve the status quo of aggressive prescribing,” said Dr. Andrew Kolodny, founder of <a href="http://www.supportprop.org/">Physicians for Responsible Opioid Prescribing</a> and an outspoken advocate for opioid reform. “They are reaping enormous profits from aggressive prescribing.”</p>
<p>The drug companies say they are committed to solving the problems linked to their painkillers. Major opioid-makers have launched initiatives to, among other things, encourage more cautious prescribing, allow states to share databases of prescriptions and help stop drug dealers from obtaining pills.&nbsp; &nbsp;</p>
<p>And the industry and its allies have not been alone in fighting restrictions on opioids. Powerful doctors’ groups are part of the fight in several states, arguing that lawmakers should not tell them how to practice medicine.</p>
<p>While drug regulation is usually handled at the federal level — where the makers of painkillers also have pushed back against attempts to impose restrictions — ordinary citizens struggling with the opioid crisis in their neighborhoods have looked to their state capitals for solutions.</p>
<p>Hundreds of opioid-related bills have been introduced at the state level just in the last several years. The few groups pleading for tighter prescription restrictions are mostly fledgling mom-and-pop organizations formed by families of young people killed by opioids. Together, they spent about $4 million nationwide at the state and federal level on political contributions and lobbying from 2006 through 2015 and employed an average of eight state lobbyists each year.</p>
<p>Prescription opioids are the synthetic cousins of heroin and morphine, prescribed to relieve pain.&nbsp; Sales of the drugs have boomed — quadrupling from 1999 to 2010 — and overdose deaths rose just as fast, totaling 165,000 this millennium. Last year, 227 million opioid prescriptions were doled out in the U.S., enough to hand a bottle of pills to nine out of every 10 American adults.</p>
<p>The drugmakers’ revenues are robust, too: <a href="http://www.purduepharma.com/">Purdue Pharma</a>, the maker of OxyContin and one of the largest opioid producers by sales, pulled in an estimated $2.4 billion from opioids last year alone, according to estimates from health care information company <a href="http://www.imshealth.com/">IMS Health</a>.</p>
<p>That’s even after executives pleaded guilty to misleading the public about OxyContin’s risk of addiction in 2007 and the company agreed to pay more than $600 million in fines.</p>
<p>Opioids can be dangerous even for people who follow doctors’ orders, though they also help millions of people manage pain associated with cancer, injuries, surgeries and end-of-life care.</p>
<p>The industry group <a href="http://www.phrma.org/">Pharmaceutical Research and Manufacturers of America</a> issued a statement saying, “We and our members stand with patients, providers, law enforcement, policymakers and others in calling for and supporting national policies and action to address opioid abuse.”</p>
<p>And Purdue said: “Purdue does not oppose — either directly or indirectly — policies that improve the way opioids are prescribed, including when those policies may result in decreased opioid use.”</p>
<p>One of the chief solutions the drugmakers actively promote now are new formulations that make their products harder to crush or dissolve, thwarting abusers who want to snort or inject painkillers. But the new versions also extend the life of their profits with fresh patents, and some experts question their overall effectiveness.</p>
<p><strong>A focus on pain treatment</strong></p>
<p>An analysis of state records collected by the <a href="http://www.followthemoney.org/">National Institute on Money in State Politics</a> provides a snapshot of the drugmakers’ battles to limit opioids. For instance, they show that pharmaceutical companies and their allies ramped up their lobbying and campaign contributions in New Mexico in 2012 as lawmakers considered — and ultimately killed — the bill backed by Cameron Weiss’ mother.</p>
<p>But one of the drug companies’ most powerful engines of political might isn’t part of the public record — a largely unknown network of opioid-friendly nonprofits they help fund and meet with monthly known as the Pain Care Forum, formed more than a decade ago.</p>
<p>Combined, its participants contributed more than $24 million to 7,100 candidates for state-level offices from 2006 through 2015, with the largest amounts going to governors and the lawmakers who control legislative agendas, such as house speakers, senate presidents and health committee chairs.</p>
<p>They’ve gotten involved in nitty-gritty fights even beyond legislatures. After Washington state leaders drafted the nation’s first set of medical guidelines urging doctors not to prescribe high doses of opioids in 2007, the <a href="https://www.publicintegrity.org/2016/09/18/20202/drugmakers-fought-domino-effect-washington-opioid-limits">Pain Care Forum hired a public relations firm</a> to convince the state medical board that the guidelines would hurt patients with chronic pain.</p>
<p>A sizable slice of the drugmakers’ battles are carried out by pharma-funded advocates spreading opioid-friendly narratives — with their links to drug companies going unmentioned — or by persuading pharma-friendly lawmakers to introduce legislation drafted by the industry.</p>
<p>Two years ago, it was a major patient organization receiving grants from the opioid industry, the <a href="https://www.acscan.org/">American Cancer Society’s Cancer Action Network</a>, that led the fight against a measure in Tennessee aimed at reducing the number of babies born addicted to narcotics.</p>
<p>And in Maine last year, drugmakers persuaded a state representative to successfully push a bill — drafted by the industry — requiring insurers to cover so-called abuse-deterrent painkillers, the new forms of opioids that are harder to abuse.</p>
<p>Legislatures have begun considering limits on the length of first-time opioid prescriptions. But the new laws and proposals in states including Connecticut and Massachusetts carve out a common exception: They do not apply to chronic pain patients. Drugmaker-funded pain groups, which can mobilize patients to appear at legislative hearings, advocate for the exceptions.</p>
<p>Many patients vouch that opioids have given them a better quality of life.</p>
<p>“There’s such a hysteria going on” about those who have died from overdoses, said Barby Ingle, president of the <a href="https://powerofpain.org/">International Pain Foundation</a>, which receives pharmaceutical company funding. “There are millions who are living a better life who are on the medications long term.”</p>
<p>That’s contrary to what researchers are increasingly saying, however. Studies have shown weak or no evidence that opioids are effective ways to treat routine chronic pain. And one 2015 study from a hospital system in Pennsylvania found about 40 percent of chronic non-cancer pain patients receiving opioids had some signs of addiction and 4 percent had serious problems.</p>
<p>“You can create an awful lot of harm with seven days of opioid therapy,” said Dr. <a href="http://sunnybrook.ca/research/team/member.asp?t=11&amp;page=172&amp;m=94">David Juurlink</a>, a toxicology expert at the University of Toronto. “You can send people down the pathway to addiction … when they never would have been sent there otherwise.”</p>
<p><strong>A surprising opponent</strong></p>
<p>Letting advocacy groups do the talking can be an especially effective tactic in state legislatures, where many lawmakers serve only part time and juggle complicated issues.</p>
<p>Lawmakers in Massachusetts, for example, said they didn’t hear directly from pharmaceutical lobbyists when they took up opioid prescribing issues this year. But they did hear from a patient advocate with ongoing back pain who works with and volunteers for groups that receive some of their funding from pharmaceutical companies. She also brought in patients to meet with them.</p>
<p>“A lot of times those legislators, they don’t have the ability to really thoroughly look into who these organizations are and who’s funding them,” said <a href="http://www.sociology.ucla.edu/faculty/edward-walker">Edward Walker</a> of the University of California Los Angeles, who studies grassroots groups.</p>
<p>Nonprofit advocacy groups led the countercharge in Tennessee in 2014 when Republican state Rep. <a href="http://www.capitol.tn.gov/house/members/h42.html">Ryan Williams</a> began work to stanch the flow of prescription painkillers, alarmed by a rapidly rising number of drug-addicted babies, who suffer from withdrawal in their first weeks of life and complications long after they leave the hospital.</p>
<p>More than 900 babies had been born addicted in Tennessee the year before, many of them hooked on the prescription opioids their mothers had taken. That number had climbed steadily since 2001, when there were fewer than 100.</p>
<p>Whitney Moore and her husband adopted two girls born addicted to prescription opioids and other drugs in eastern Tennessee, and she still remembers her older daughter’s cries in the hospital, “the most high-pitched scream you’ve ever heard in your life”— a common symptom in babies in the throes of withdrawal.</p>
<p>Doctors gave Moore’s infant daughter morphine to ease her seizures, vomiting and diarrhea, and she stayed in a neonatal intensive care unit more than a month. Now 3 years old, she still suffers from gastrointestinal problems and remains sensitive to loud noises.</p>
<p>When Williams was mulling potential legislation, doctors told him that part of Tennessee’s problem was a 2001 law — similar to measures on the books in more than a dozen states — that made it difficult to discipline doctors for dispensing opioids and allowed clinicians to refuse to prescribe powerful narcotics only if they steered patients to an opioid-friendly doctor.</p>
<p>The result, according to the experts Williams worked with, was a rash of prescribing, even for pregnant women. In 2014, Tennessee ranked third in the country for per-capita opioid prescriptions, with roughly 1.3 prescriptions doled out for every person in the state, according to an analysis of prescription data from IMS Health.</p>
<p>Williams’ mission to repeal the law failed that year, and he was shocked by the group that came out in opposition — the American Cancer Society Cancer Action Network, the advocacy arm of one of the country’s biggest and best-known charities.</p>
<p>Two Cancer Society lobbyists worked against the bill, even though prescribing painkillers for cancer patients is a widely accepted medical practice that would have remained legal. &nbsp;</p>
<p>“We injected ourselves into the debate because we did not want cancer patients to not be able to have access to their medication,” said Theodore Morrison, a lobbyist working for the network that year.</p>
<p>The society’s annual ranks of about 200 lobbyists around the country have taken similar positions elsewhere, defending rules that some argue encourage extensive prescriptions and opposing opioid measures even if the proposed legislation specifically exempted cancer patients.</p>
<p>The Cancer Action Network listed four major opioid makers that provided funding of at least $100,000 in 2015, in addition to five that contributed at least $25,000. Companies that donate such sums get <a href="https://web.archive.org/web/20160419122858/http://www.acscan.org/corporatemembers">one-on-one meetings</a> with the group’s leaders and other chances to discuss policy.</p>
<p>The network said only 6 percent of its funding last year came from drugmakers and that its ties to drug companies do not influence the positions it takes. “ACS CAN’s only constituents are cancer patients, survivors, and their loved ones nationwide,” spokesman Dave Woodmansee said.</p>
<p>The network said it advocates for certain measures despite exemptions for cancer because some patients continue to experience pain even after their cancer is gone.</p>
<p>ACS CAN teamed up with another group to defend the Tennessee painkiller law — the Academy of Integrative Pain Management, an association of doctors, chiropractors, acupuncturists and others who treat pain, until recently known as the <a href="http://www.aapainmanage.org/">American Academy of Pain Management</a>. The group promotes access to pain drugs as well as non-pharmaceutical treatments such as acupuncture.</p>
<p>Seven of the academy’s nine corporate council members <a href="http://webcache.googleusercontent.com/search?q=cache:http://www.aapainmanage.org/about/corporate-council/">listed online</a> are opioid makers. The other two are <a href="https://www.astrazeneca.com/">AstraZeneca</a>, which has invested heavily in a drug to treat opioid-induced constipation, and Medtronic, which makes implantable devices that deliver pain medicine.</p>
<p>The academy’s executive director, Bob Twillman, said his organization receives 15 percent of its funding from pharmaceutical companies, not including revenue from advertisements in its publications. Its <a href="https://web.archive.org/web/20160305130145/http://sppan.aapainmanage.org/">state advocacy project</a> is 100 percent funded by drugmakers and their allies, but he said that does not mean it is beholden to pharmaceutical interests.</p>
<p>“We don’t always do the things they want us to do,” he said. “Most of the time we’re saying, ‘Gosh, yes, there should be some limits on opioid prescribing, reasonable limits,’ but I don’t think they would be in favor of that.”</p>
<p>Both the academy and the cancer group have been active across the country, making the case that lawmakers should balance efforts to address the opioid crisis with the needs of chronic pain patients. Between them, they have contacted legislators and other officials about opioid-related measures in at least 18 states.</p>
<p>In Massachusetts this year, they helped persuade lawmakers to soften strict proposals that would have limited first-time opioid prescriptions to three days’ worth. They also have weighed in on how often doctors should be required to check prescription-monitoring databases, which can help crack down on prescription-shopping with multiple doctors.</p>
<p>The academy reported on its website that, since 2013, its state advocacy network had provided “extensive comments” on clinician guidelines in New Mexico, Pennsylvania, Indiana and elsewhere; issued action alerts resulting in more than 300 emails and phone calls to more than 80 legislators in 2014 alone; and held teleconferences with more than 100 advocates.</p>
<p>Purdue, which gives to both the academy and the cancer network, said it contributes to a range of advocacy groups, including some with differing views on opioid policy. “It is imperative that we have legitimate policy debates without trying to silence those with whom we disagree. That’s the American political system at work,” the company said in a statement.</p>
<p>As for Williams, he tried again last year to repeal Tennessee’s intractable pain law — and won unanimous approval in both houses.&nbsp; The extra year had given Williams and his co-sponsor time to help educate their fellow lawmakers, he said, even though the Cancer Society still opposed the repeal.</p>
<p><strong>Lobbyists ‘were killing it’</strong></p>
<p>The tried-and-true tactics of lobbying and campaign contributions remain a major plank of the pharmaceutical playbook. In 2014 alone, for instance, participants in the Pain Care Forum spent at least $14 million nationwide on state-level lobbying.</p>
<p>Two years earlier — facing the threat of limits on opioid-prescribing — forum members had upped their number of lobbyists in New Mexico, which is second only to West Virginia in per-capita deaths primarily due to prescription and illegal opioid drugs, according to the most recent federal data available.</p>
<p>The aim of the bill Jennifer Weiss-Burke backed was to limit initial prescriptions of opioids for acute pain to seven days to make addictions less likely and produce fewer leftover pills that could be peddled illegally.</p>
<p>After her son had left the hospital with his first bottle of Percocet in 2009 at the age of 16, the Albuquerque teen had suffered two more injuries and gotten two more prescriptions. He also took pills he found at his grandparents’ house. Less than a year later, he started smoking heroin, which costs less than black-market prescription drugs.</p>
<p>He repeatedly went into rehab, and just as repeatedly relapsed. In August 2011, his mother found him at home, dead.</p>
<p>Weiss-Burke said she didn’t realize how dangerous prescription pills could be until her son already had moved on to heroin, a tortuous progression mirrored by the downward spirals of tens of thousands of other people across the country.</p>
<p>Heeding concerns from the state medical society, the bill’s sponsors amended it to allow the boards overseeing doctors and other prescribers to set their own limits. Still, the bill died in the House Judiciary Committee.</p>
<p>“The lobbyists behind the scenes were killing it,” said Bernadette Sanchez, the Democratic state senator who sponsored the measure.</p>
<p>Lobbyists for three Pain Care Forum members declined to comment, saying they were not authorized to speak about their clients’ work.</p>
<p>Forum participants had 15 lobbyists registered in New Mexico that year, up from nine the previous year. One was reported to be working out of the office of a high-ranking lawmaker; another was a former lawmaker himself.</p>
<p>Pfizer said that its two lobbyists in Santa Fe — up from one — reflected a change in firms, not an addition, and that the company did not lobby on opioid restrictions.</p>
<p>Still, the majority of the judiciary committee received drug industry contributions in 2012. Overall that year, drug companies and their employees contributed nearly $40,000 to New Mexico campaigns — roughly 70 percent more than in previous years with no governor’s race on the ballot.</p>
<p>In New Mexico alone, opioid makers spent $32,000 lobbying in 2012 — more than double their outlay the year before.</p>
<p>Restrictions like the ones considered in New Mexico did not become law anywhere until this year, after the U.S. Centers for Disease Control and Prevention <a href="http://www.cdc.gov/drugoverdose/prescribing/guideline.html">called for even tighter restrictions</a>. In 2016, they have been adopted in Connecticut, Maine, Massachusetts, New York and Rhode Island, all with exceptions for patients with chronic pain.</p>
<p><strong>The next frontier</strong></p>
<p>Now, pharmaceutical companies are directing their lobbying efforts to their new legislative frontier in the states — medicines known as abuse-deterrent formulations. These drugs ultimately are more lucrative, since they’re protected by patent and do not yet have generic competitors. They cost insurers more than generic opioids without the tamper-resistant technology.</p>
<p>Skeptics warn that they carry the same risks of addiction as other opioid versions, and the U.S. Food and Drug Administration noted that they don’t prevent the most common form of abuse — swallowing pills whole.</p>
<p>“This is a way that the pharmaceutical industry can evade responsibility, get new patents and continue to pump pills into the system,” said Dr. <a href="https://med.stanford.edu/profiles/anna-lembke;jsessionid=36EB7E13C1638E457EF53C813959CE86.tc-cap-som-07">Anna Lembke</a>, chief of addiction medicine at the Stanford University School of Medicine and author of a book on the opioid epidemic.</p>
<p>Opioid-makers have especially courted attorneys general, who have helped&nbsp;spread&nbsp;tamper-resistant opioid talking points.</p>
<p>Since 2006, Pain Care Forum participants have given more than $600,000 in campaign contributions to attorneys general candidates, and another $1.6 million to the Republican and Democratic attorneys general associations. Purdue, with $100,000 in 2015 alone, tied with four other entities for top contributor to the <a href="http://www.democraticags.org/">Democratic Attorneys General Association</a>; it was among the top 10 donors to the <a href="http://www.republicanags.com/">Republican group</a>, giving more than $200,000.</p>
<p>In 2013, Alabama’s Republican attorney general, <a href="http://www.ago.state.al.us/Page-Biography">Luther Strange</a>, helped spearhead a <a href="http://www.naag.org/assets/files/pdf/signons/20130311.Final%20FDA%20Letter.pdf">letter to the FDA</a> recommending the agency not approve new generic versions of opioids without tamper-resistant technology, which effectively would give the market to brand-name drug companies such as Purdue and Pfizer for several years. In all, 48 attorneys general, including Strange, <a href="http://www.naag.org/assets/files/pdf/signons/20130311.Final%20FDA%20Letter.pdf">signed the letter</a>.</p>
<p>Strange has received $50,000 in campaign contributions from Pain Care Forum members, more than any other attorney general from 2006 through 2015, with more than $20,000 of that coming from Pfizer.</p>
<p>“As Attorney General, I will not apologize for my efforts to protect Alabamians from a drug abuse epidemic that is claiming more lives than automobile accidents in my state,” Strange said.</p>
<p>More than 100 bills related to abuse-deterrent opioids have been introduced in various states thus far, at least 81 of them since January 2015, according to the legislative tracking service <a href="https://www.quorum.us/">Quorum</a>. At least 21 of the recent bills featured nearly identical language, and several of their sponsors said they received the wording from pharmaceutical lobbyists.</p>
<p>In Maine last year, a measure that required insurers to cover abuse-deterrent opioids at more favorable rates was introduced at the request of a lobbyist and sailed through the Legislature, after overdose deaths in the state hit a record peak.</p>
<p>Insurance lobbyists argued in vain against the measure, saying it would allow drug companies to raise prices and push up insurance premiums.</p>
<p>The bill’s sponsor, Democratic Rep. <a href="https://legislature.maine.gov/house/hsebios/hobbbj.htm">Barry Hobbins</a>, has a family member struggling with opioid addiction and said he was asked to introduce the bill by a longtime acquaintance who also lobbies for Pfizer.</p>
<p>“Everyone was trying to figure out a way to do anything they could to address this major health crisis,” Hobbins said. “I was asked to sponsor that bill because of my personal family issues.”</p>
<p>Pushing for the legislation was a team effort: Pfizer’s director of U.S. policy <a href="https://www.documentcloud.org/documents/3109140-PoliticsofPainPfizerTestimony.html">testified in favor of the bill</a>, citing a study that showed it would help curb abuse. But he neglected to say the study was co-authored by employees of Purdue, which also sent a lobbyist to push for the bill.</p>
<p>The drugmakers tried similar tactics in New Mexico earlier this year, with less success.</p>
<p>Randy Marshall, director of the <a href="http://www.nmms.org/">New Mexico Medical Society</a>, which represents doctors, said he turned down a request from a Purdue lobbyist that he introduce a measure calling for tamper-resistant drugs to be covered by insurers. He said he was told that if he testified, the company would lobby behind the scenes.</p>
<p>But the <a href="http://www.nmoma.org/">New Mexico Osteopathic Medical Association</a> did help at the request of a Pfizer lobbyist, said the group’s executive director, Ralph McClish.</p>
<p>In response to a question about its role in that legislation, Pfizer issued a statement that it “works with many different stakeholders on areas of mutual interest.”</p>
<p>A Purdue statement acknowledged that the abuse-deterrent pills won’t stop all misuse, but added, “They are an important part of the comprehensive approach needed to address this public health issue.”</p>
<p>The New Mexico measure failed, and McClish said that the perceived self-interest of the drug companies was key to its defeat.</p>
<p>“People were sitting there going, ‘Pharma is going to make a lot of money off of these drugs,’” he said.</p>
<p><em>Associated Press health reporter Matthew Perrone contributed to this article.</em></p>
<p><strong><em>This story was co-published with <a href="http://bigstory.ap.org/article/86e948d183d14091a80f5c3bfb429c68/drugmakers-fought-state-opioid-limits-amid-crisis">The Associated Press</a>.</em></strong></p>
Jennifer Weiss-Burke, executive director of a youth recovery center in Albuquerque, N.M., stands by one of the rooms at the recovery center named after her son, Cameron Weiss. He died of a heroin overdose in 2011. Weiss-Burke&nbsp;said her teenage son's descent into drug addiction started with an opioid prescription a doctor wrote for him for a wrestling injury.
Liz Essley Whytehttps://www.publicintegrity.org/authors/liz-essley-whyteGeoff Mulvihillhttps://www.publicintegrity.org/authors/geoff-mulvihillBen Wiederhttps://www.publicintegrity.org/authors/ben-wiederDrugmakers fought domino effect of Washington opioid limitshttp://www.publicintegrity.org/node/20202Fearing ‘domino effect’ when Washington state came up with new rules for opioid prescribing, a network of drugmakers and allies pushed back.Opioids;Domino Effect;Domino;Phenols;Neurochemistry;Thiophenes;Pyrrolidines2016-09-21T15:30:25-04:002016-09-18T00:01:00-04:00<p>When Washington state made one of the first major moves to place limits on opioid painkiller prescriptions, pharmaceutical companies fought back — using the <a href="https://www.publicintegrity.org/2016/09/19/20201/pro-painkiller-echo-chamber-shaped-policy-amid-drug-epidemic">Pain Care Forum</a>, a national network of drug companies and opioid-friendly nonprofits, many of them funded by drugmakers.</p>
<p>Alarm bells rang at the forum in 2007 after Washington state’s agency medical directors — spurred by overdose deaths of patients in the worker’s compensation system — drafted guidelines that would require pain specialists to approve high doses of opioids.</p>
<p>Worried the guidelines would create a “domino effect” of <a href="https://www.publicintegrity.org/2016/09/18/20200/politics-pain-drugmakers-fought-state-opioid-limits-amid-crisis">other states adopting restrictive policies</a>, the forum agreed to pay <a href="https://www.documentcloud.org/documents/3109056-MemoWashingtonGuidelines.html">a public relations consultant $85,000</a> to prep speakers, draft patient testimonials and coordinate an educational initiative focused on elected officials and the state medical board, documents obtained by the <a href="http://www.publicintegrity.org/">Center for Public Integrity</a> and <a href="http://bigstory.ap.org/article/306d420ce68f487dbe12b8603891dc03/drugmakers-fought-domino-effect-washington-opioid-limits">The Associated Press</a> reveal.</p>
<p>The core message of the campaign: Patients should have access to painkillers.</p>
<p><a href="http://www.purduepharma.com/">Purdue Pharma</a> also wrote one of the Washington medical directors, <a href="https://www.documentcloud.org/documents/3109074-PoliticsofPain-Purdue-Letter.html">calling the new proposed guidelines too tough</a>. The company knew the role painkillers have played in America’s addiction crisis: Its executives pleaded guilty to misleading the public about their drug OxyContin’s risk of addiction that year.</p>
<p>The same internal memos show that advocates affiliated with the Pain Care Forum met with the Washington governor’s chief health adviser to discuss the "unintended consequences" of the guidelines. They also helped defeat a resolution from the state medical association, which represents doctors,&nbsp; that would have supported the guidelines.</p>
<p>The state medical board, which oversees doctors, also agreed to do something the Pain Care Forum wanted: send doctors a book on opioid prescribing produced by the <a href="https://www.fsmb.org/">Federation of State Medical Boards</a>, a group that has received some funding from pharmaceutical companies.</p>
<p>Drugmakers <a href="https://www.documentcloud.org/documents/3109089-FSMB-Response-Letter-to-US-Senate.html#document/p12/a318151">paid $825,000 to distribute the book</a> in dozens of states, according to information the FSMB provided as part of a U.S. Senate investigation. FSMB guidelines, which some doctors said were too lax, were enshrined by medical boards in at least 35 states as of 2013.</p>
<p>Lisa Robin, FSMB’s chief advocacy officer, said those guidelines reflected the best practices at the time. The federation has since updated both those and the prescribing book, and no longer receives funding from pharmaceutical companies, she said.</p>
<p>The drug industry relied upon lobbyists and political contributions when the guidelines went before the Washington Legislature in 2010. Though Purdue spent next to nothing in prior years, state records show it laid out more than $62,500 that year on lobbying. It also gave $800 each to five state senators; four of them voted against the dosing limits.</p>
<p>Still, the guidelines passed.</p>
<p>“I think we kind of caught them with their pants down,” said Democratic Rep. <a href="http://housedemocrats.wa.gov/legislators/jim-moeller/">Jim Moeller</a>, the bill’s sponsor. “They didn’t expect this was going to have any legs.”</p>
<p>Purdue said that it does not oppose measures that “improve the way opioids are prescribed,” even when they could reduce opioid sales, but did not respond to questions about its activities in Washington.</p>
<p>After the guidelines became state law, the advocacy groups’ fight continued. The American Pain Foundation, a member of the Pain Care Forum that received most of its funding from the industry, asked at least one pharmaceutical company for money in 2011, warning that other states could soon follow Washington. A week later, the company sent a check for $75,000.</p>
<p>The state has seen a slower increase in overdose deaths than nearly all others since the policy was implemented. Some patients have had difficulty finding pain specialists in rural areas, however.</p>
<p>Overall, the episode didn’t lead to a total loss for opioid makers: Few other states have adopted Washington’s approach discouraging high doses of the drugs.</p>
<p><strong><em>This story was co-published with&nbsp;<a href="http://bigstory.ap.org/article/306d420ce68f487dbe12b8603891dc03/drugmakers-fought-domino-effect-washington-opioid-limits">The Associated Press</a>.</em></strong></p>
A decade ago, when Washington state made one of the first major moves to place limits on opioid painkiller prescriptions, drugmakers fought back. The&nbsp;Washington State Legislature, pictured here in 2016,&nbsp;approved the policy&nbsp;anyway.&nbsp;
Geoff Mulvihillhttps://www.publicintegrity.org/authors/geoff-mulvihillLiz Essley Whytehttps://www.publicintegrity.org/authors/liz-essley-whyte